FDA 510(k)

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION

K-Number: K053197 · 2005-12-15

Decision Date2005-12-15

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Neurovascular, Inc.. It received FDA 510(k) clearance on 2005-12-15 under 510(k) number K053197. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION?

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2005-12-15. The listed applicant is Cordis Neurovascular, Inc.. The 510(k) number is K053197.

When did TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION receive FDA 510(k) clearance?

TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION received FDA 510(k) clearance on 2005-12-15, under 510(k) number K053197.

Who is the listed applicant for TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION?

The FDA 510(k) record lists Cordis Neurovascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION?

The FDA product code for TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM LINE EXTENSION is HCG.

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Other records listing Cordis Neurovascular, Inc. as applicant

K082324TRUFILL DCS SYRINGE K080967TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT K071962VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS AND TRUPUSH COIL PUSHER)K070279MODIFICATION TO HYPERTRANSIT INFUSION CATHETER K063254THE TRUFILL DCS DETACHABLE COIL SYSTEM; THE TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM K043538HYPERTRANSIT INFUSION CATHETER

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Related Devices (Code: HCG)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.